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BUPRADONE 8/2 buprenorphine (as hydrochloride) 8 mg and naloxone (as hydrochloride dihydrate) 2 mg sublingual tablet - TGA Drug Approval Details
Approvals
/
TGA
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BUPRADONE 8/2 buprenorphine (as hydrochloride) 8 mg and naloxone (as hydrochloride dihydrate) 2 mg sublingual tablet
Approved
STANDARD
BUPRADONE 8/2 buprenorphine (as hydrochloride) 8 mg and naloxone (as hydrochloride dihydrate) 2 mg sublingual tablet
Indivior Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
586ba7c5f8f3f7b1
Company
Indivior Pty Ltd
Type
Standard
Approval Details
Approval Id
586ba7c5f8f3f7b1
Product Name
BUPRADONE 8/2 buprenorphine (as hydrochloride) 8 mg and naloxone (as hydrochloride dihydrate) 2 mg sublingual tablet
Artg Id
152484
Artg Name
BUPRADONE 8/2 buprenorphine (as hydrochloride) 8 mg and naloxone (as hydrochloride dihydrate) 2 mg sublingual tablet
Sponsor
Indivior Pty Ltd
Company Detail Path
/organization/indivior-pty-ltd
Artg Date
2008-09-09
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
586ba7c5f8f3f7b1
Type
Standard
Back to TGA Approvals